Australia Looks to Improve Generic Drug Authorization Process
Posted 07 February 2019 | By
Australia’s Therapeutic Goods Administration (TGA) announced Thursday that it’s considering a range of options to improve the generic medicine registration process.
Chief among those options is TGA’s consideration to allow the use of overseas reference product in bioequivalence studies, as currently the reference product used in such studies must be an existing medicine approved in Australia.
“Our requirements are largely consistent with comparable overseas regulatory agencies, such as those in Europe and Canada. However, some agencies such as those in Switzerland and Singapore, do not always rely on the same way of demonstrating ‘identicality,’” TGA says. “Under certain conditions, there is less emphasis placed on confirming the exact quantities of the non-active ingredients. We are investigating whether similar approaches could also be applied in Australia.”
TGA is also considering introducing ways to allow applicants to seek formal scientific advice on a proposed justification for a biowaiver, which the regulator says could reduce unnecessary bioequivalence studies and would remove uncertainty about the acceptability of a proposed justification before the full dossier is finalized and submitted.
In addition, TGA is exploring the use of international templates to improve opportunities for joint submissions to multiple regulators and expedited applications to encourage generic medicines of special interest, such as those in shortage or when the cost of the reference product is a significant burden for the Australian health system.
Interested parties should respond to the consultation by 21 March.
Consultation: Reforms to the generic medicine market authorisation process